RecruitingNot ApplicableNCT07474909

Perineural vs Intravenous Dexamethasone as an Adjuvant to Brachial Plexus Block in Pediatric Hand Surgery

Comparison of Perineural Versus Intravenous Dexamethasone as an Adjuvant to Brachial Plexus Block in Pediatric Hand and Forearm Surgery: A Randomized Double-Blind Placebo-Controlled Trial With Neurological Safety Evaluation and Neurofilament Light Chain Biomarker Assessment


Sponsor

Poznan University of Medical Sciences

Enrollment

150 participants

Start Date

Dec 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial will evaluate the neurological safety and analgesic effectiveness of dexamethasone administered perineurally or intravenously as an adjuvant to brachial plexus block in children undergoing hand or forearm surgery. Dexamethasone is commonly used to prolong the duration of regional anesthesia, but there is limited evidence on long-term neurological safety, particularly in pediatric patients. All participants will receive a single-shot brachial plexus block using ropivacaine under ultrasound guidance. Patients will be randomized into one of three treatment groups: perineural dexamethasone, intravenous dexamethasone, or placebo. The primary objective is to determine whether perineural dexamethasone causes any clinically significant nerve injury compared with intravenous administration or placebo. Neurological function will be assessed clinically and via serum neurofilament light chain (NfL) levels over a 12-month follow-up period. This study may provide evidence regarding the long-term safety profile of perineural dexamethasone in children and help establish evidence-based dosing and administration guidelines.


Eligibility

Min Age: 3 MonthsMax Age: 16 Years

Inclusion Criteria5

  • Age 3 months to 16 years
  • Scheduled elective hand or forearm surgery under general anesthesia with a brachial plexus block
  • ASA physical status I-III
  • Planned use of ultrasound-guided regional anesthesia
  • Written informed consent from parent(s) or legal guardian and age-appropriate assent from the child

Exclusion Criteria12

  • Pre-existing neurological disease or peripheral neuropathy
  • Preoperative sensory deficit in the operative limb
  • Infection at or near the needle insertion site
  • Coagulopathy or therapeutic anticoagulation
  • Systemic infection or sepsis
  • Chronic steroid therapy within 30 days before surgery
  • Known allergy to ropivacaine or dexamethasone
  • Diabetes mellitus
  • BMI > 99th percentile for age and sex.
  • Pregnancy or breastfeeding
  • Participation in another interventional clinical trial within 30 days
  • Refusal of consent

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Interventions

DRUGiv dexamethasone

Participants in this arm will receive intravenous dexamethasone at a dose of 0.1 mg/kg (maximum 8 mg) administered immediately before the brachial plexus block. A perineural placebo (0.9% normal saline) will be added to the local anesthetic syringe for the nerve block in order to maintain blinding.

DRUGpn dexamethasone

Participants in this arm will receive dexamethasone administered perineurally at a dose of 0.1 mg/kg (maximum 4 mg) mixed with the local anesthetic solution for the brachial plexus block. An intravenous placebo (0.9% normal saline) will be administered immediately before the block to maintain blinding.

DRUG0.9%NaCl

Participants in this arm will receive placebo both intravenously and perineurally. Normal saline will be added to the local anesthetic solution for the brachial plexus block and administered intravenously in volumes matching the active treatment groups in order to maintain blinding.


Locations(1)

Poznan University of Medical Sciences

Poznan, Poland

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NCT07474909


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